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Suspension for intramuscular and subcutaneous administration.The vaccine is a purified surface antigens (haemagglutinin and neuraminidase) of influenza A and B viruses grown on a culture of chicken embryos that have been inactivated by formaldehyde.

Composition:

Name of component

Amount in a dose, 0.5 ml

Active components:

A (H1N1) *

15 μg GA **

A (H3N2) *

15 μg GA **

AT *

15 μg GA **

Auxiliary components:

Sodium chloride

4.00 mg

Potassium chloride

0.10 mg

Potassium hydrogen phosphate

0.10 mg

Sodium hydrogen phosphate dihydrate

0.66 mg

Magnesium chloride

0.05 mg

Calcium chloride

0.06 mg

Water for injections

0.50 ml

* Identify the antigens that make up the vaccine, which are updated annually in accordance with the recommendations of the World Health Organization (WHO).

** Hemagglutinin.


Description:

Colorless transparent liquid.

Pharmacotherapeutic group:MIBP vaccine
Pharmacodynamics:

IMMUNOLOGICAL PROPERTIES

The protective level of antibodies usually develops 2-3 weeks after vaccination, the duration of immunity is from 6 to 12 months.

Indications:

Prevention of influenza in children from 6 months of age, adolescents and adults, without age restriction.

Vaccination is also indicated to persons,having a high risk of influenza, namely children, students of grades 1-11; students of higher professional and secondary vocational schools; adults working for certain professions and positions (employees of medical and educational institutions, transport, communal sphere, etc.); adults over 60 lay down.

Vaccination is also indicated to the rest of the population.

Contraindications:

Hypersensitivity to any of the active and auxiliary components of the vaccine, including technological impurities (see section "Special instructions and precautions for use"), increased sensitivity to chicken protein. Allergic reactions to the previous vaccination.

Pregnancy and lactation:

Pregnancy

The limited experience of use in pregnant women does not indicate an undesirable effect of the vaccine Agrippal S1 on the fetus and the mother's body. This vaccine can be used from the second trimester of pregnancy.

Pregnant women who are at risk of developing complications after influenza infection, vaccination for medical reasons is recommended at any time of pregnancy.

The decision to vaccinate a pregnant woman should be taken by a doctor individually, taking into account the risk of contracting influenza and possible complications of influenza infection.

Lactation

Vaccination Agrippal S1 can be performed during the entire lactation period.

Dosing and Administration:

Method of administration

The vaccine is injected intramuscularly into the deltoid muscle or deeply subcutaneously. In young children, the vaccine is injected into the upper-outer surface of the middle third of the thigh.

Vaccination schedules

Before introduction bring to room temperature.

Shake thoroughly.

Adults, adolescents and children from 36 months: 1 dose - 0.5 ml

Children from 6 months. up to 35 months: half of the dose - 0.25 ml

Children who have not previously been vaccinated are recommended to be vaccinated twice with an interval of 4 weeks.

If a syringe containing 0.5 ml vaccine is used to immunize the children and half the dose (0.25 ml) is indicated, half of the contents of the syringe (up to 0.25 ml) should be removed by pressing the piston. The patient should be given the remaining amount of the vaccine.

It is recommended to vaccinate annually.

Side effects:
The adverse events presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence.
Frequency of occurrence is defined as follows: very often (> 1/10), often (> 1/100 and <1/10), infrequently (> 1/1 000 and <1/100). rarely (> 1/10 000 and <1/1 000), very rarely (<1/10 000. including individual cases). Frequency categories were formed on the basis of clinical studies of the drug.
Frequency of occurrence of undesirable phenomena
Disturbances from the nervous system
Often: headache.
Disturbances from the skin and subcutaneous tissues
Often: sweating.
Disturbances from the musculoskeletal system and connective tissue Often: myalgia, arthralgia.
General disorders and disorders at the site of administration
Often: fever, malaise, chills, weakness.
Redness, swelling in the area of ​​injection, soreness, bruising, compaction at the injection site.
These phenomena usually pass independently after 1-2 days.
Adverse events observed during post-marketing surveillance
Disturbances from the hematopoietic and lymphatic system: thrombocytopenia, transitional lymphadenopathy.
Disturbances from the immune system: allergic reactions, in rare cases leading to the development of shock, angioedema.
Impaired nervous system: neuralgia, paresthesia (unusual sensations such as burning, numbness, etc.), febrile convulsions, neurological disorders such as encephalomyelitis, neuritis, Guillain-Barre syndrome (acute polyneuropathy).
Vascular disorders: vasculitis, in very rare cases with transient involvement of the kidneys.
Disturbances from the skin and subcutaneous tissues: generalized reactions from the skin, including itching, hives, rashes.
If undesirable effects occur, consult a physician.
The patient should also be informed of the need to inform the physician of any unusual undesirable phenomena not described in this manual.
Interaction:

Application of Agrippath vaccine S1 is possible simultaneously with other vaccines, provided that the vaccines are administered with different syringes and in different parts of the body. In this case, contraindications to each of the vaccines used should be taken into account, as well as the possibility of intensifying the intensity of adverse reactions.

In patients receiving immunosuppressive therapy, as well as in individuals with congenital and acquired immunodeficiency, vaccination may be less effective.

After vaccination against influenza, false positive results were detected for the determination of antibodies by the method ELISA against HIV infection (H1V1), viral hepatitis C and especially against human lymphotropic virus 1 (HTLV1). To avoid a false positive result, Western Blot.

Short-term false positive results may be associated with the appearance of immunoglobulin IgM as a result of vaccination.
Special instructions:

Vaccine Agrippal S1 ns should be mixed with other medicinal substances. As with other injectable vaccines, funds should always be available for use in the development of rare anaphylactic reactions.

It is strictly forbidden to administer the drug intravenously.

In patients with immunocompromised conditions, both endogenous and post-therapy immunosuppressive drugs, the immune response may not be sufficient.

Agrippal S1 contains ns more than 0.2 μg ovalbumin (chicken egg white) in 0.5 ml or ns more than 0.1 μg ovalbumin in 0.25 ml.

If there is a high temperature and / or acute infectious diseases, vaccination should be postponed until complete recovery.

The vaccine may contain residual amounts (technological impurities) of the following substances: eggs, chicken protein, kanamycin and neomycin sulfate, formaldehyde,andcetyltrimethylammonium bromide (1 (TAB), polysorbate 80, which were used in the manufacturing process.

Vaccination should be carried out if possible before the start of the influenza season (in the autumn-winter period). However, depending on the epidemic situation, it may be necessary to conduct it at another time of the year.

Effect on the ability to drive transp. cf. and fur:

It is unlikely that the vaccine has an effect on the ability to drive or use machines and mechanisms.

Form release / dosage:

Suspension for intramuscular and subcutaneous administration.

Packaging:For 0.5 ml (1 dose) into a sterile syringe made of hydrolytic glass, type I with a needle. One syringe in a blister made of polyvinylchloride (PVC) or polyethyl- nisphthalate (PET). One blister with instructions for use in a pack of cardboard.
Storage conditions:

STORAGE CONDITIONS

Store in a dark place at a temperature of +2 to +8 ° C. Do not freeze. Keep out of the reach of children.

CONDITIONS OF TRANSPORTATION

Transport in a dark place at a temperature of +2 to +8 ° C, do not freeze.

Shelf life:

12 months.

Do not use after the expiration date stated on the package.

Expiration date is the last day of the month indicated on the package.

Terms of leave from pharmacies:On prescription
Registration number:П N012054 / 01
Date of registration:23.03.2007/19.05.2015
Date of cancellation:2016-02-29
The owner of the registration certificate:Novartis Vaccines & Diagnostics Sr.L. Novartis Vaccines & Diagnostics Sr.L. Italy
Manufacturer: & nbsp
Representation: & nbspNOVARTIS CONSUMER HELS S.A. (part of Novartis groups) NOVARTIS CONSUMER HELS S.A. (part of Novartis groups) Switzerland
Information update date: & nbsp23.01.2017
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